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IceCure Highlights Two New Peer-Reviewed Publications Supporting Cryoablation in Breast Cancer Treatment De-Escalation

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IceCure Medical (NASDAQ: ICCM) highlighted two new peer-reviewed U.S. publications supporting the role of its ProSense® cryoablation system in breast cancer treatment de-escalation. One review in Clinical Breast Cancer discusses clinical evidence, procedural aspects and ProSense®'s FDA marketing authorization, its inclusion in updated American Society of Breast Surgeons guidelines, and five-year ICE3 trial outcomes showing a 3.1% IBTR rate in selected patients.

A second article in the Journal of Breast Imaging addresses cryoablation of axillary lymph node metastases for breast cancer patients who are poor surgical candidates or decline surgery, reporting high technical success and low complication rates in both curative and palliative settings, and broadening discussion beyond primary tumors to regional nodal disease.

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Positive

  • ProSense® received FDA marketing authorization and was included in updated ASBrS guidelines
  • ICE3 five-year results reported a 3.1% IBTR rate in selected early-stage, low-risk breast cancers
  • Two peer-reviewed U.S. publications support breast cryoablation in treatment de-escalation strategies
  • Axillary lymph node cryoablation reported high technical success and low complication rates
  • Publications may support broader clinical adoption and commercialization of ProSense®

Negative

  • None.

Market Context

The effective F-3 registration covers resale of up to 5,500,002 ordinary shares by a selling shareho...
Analysis

The effective F-3 registration covers resale of up to 5,500,002 ordinary shares by a selling shareholder, while low short positioning provides limited evidence of concentrated short exposure; adoption evidence remains the central platform context.

Key Figures

Peer-reviewed publications: 2 publications ICE3 follow-up: five years IBTR rate: 3.1% +1 more
4 metrics
Peer-reviewed publications 2 publications Breast cancer cryoablation
ICE3 follow-up five years ICE3 clinical study
IBTR rate 3.1% Five-year ICE3 clinical study
Authorized patient age 70 years and older Selected early-stage, low-risk breast cancers

Historical Context

5 past events · Latest: Aug 12 (Neutral)
Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Aug 12 First-half earnings Neutral -11.5% Revenue growth and higher gross profit accompanied by wider losses and going-concern concerns
Aug 6 Clinical study site Positive -4.0% Adventist Health became first U.S. site able to enroll ChoICE Study patients
Aug 5 Earnings date notice Neutral +2.6% Company scheduled first-half financial and operating results for August 12
Jul 29 Guideline petition Positive +3.2% SIO petitioned NCCN to include cryoablation for selected breast cancer patients
Jul 27 Clinical study launch Positive -6.5% ChoICE Study began at its first U.S. clinical site for low-risk breast cancer

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent company announcements were more often followed by negative price reactions than by reactions aligned with their constructive or neutral content.

Key Terms

cryoablation, treatment de-escalation, axillary lymph node metastases, marketing authorization
4 terms
cryoablation medical
"clinical role of cryoablation in breast cancer treatment de-escalation"
A medical treatment that uses extreme cold to freeze and destroy unwanted tissue, such as small tumors or heart tissue causing irregular rhythms; think of it like applying a focused freezer to stop a problem spot without cutting it out. It matters to investors because devices, tools, and drugs tied to cryoablation, plus clinical results, approval status and insurance coverage, can drive sales, shape market adoption and affect the financial outlook of healthcare companies.
treatment de-escalation medical
"breast cancer treatment de-escalation"
Treatment de-escalation is the intentional lowering of the intensity, duration, or amount of a medical therapy while still aiming to keep the same health benefit; think of turning down the volume until you can still hear the song clearly. For investors, it matters because successful de-escalation can reduce drug or care costs, widen a therapy’s patient pool by making it safer or easier to use, and change future revenue forecasts and regulatory pathways for medical products.
axillary lymph node metastases medical
"cryoablation to axillary lymph node metastases"
Cancer cells that have spread from a primary tumor to the lymph nodes located under the arm (the axilla). Think of lymph nodes as small checkpoints along the body's drainage routes; when cancer reaches these nodes it changes how doctors stage the disease, choose treatments, and assess prognosis, which in turn can affect clinical trial outcomes, regulatory decisions, and the financial value of related therapies or diagnostics.
marketing authorization regulatory
"ProSense® FDA marketing authorization"
An official government approval that allows a drug, vaccine, or medical device to be sold and promoted in a specific country or region. Think of it as a safety and effectiveness passport issued after regulators review the product’s tests and manufacturing; for investors, receiving this authorization typically unlocks sales, revenue potential, and lower regulatory risk, while delays or denials can substantially affect a company’s value and timeline.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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New review by leading U.S. experts highlights ProSense® FDA marketing authorization, updated American Society of Breast Surgeons guidelines, and encouraging outcomes from the five-year ICE3 clinical trial while a second publication extends cryoablation's clinical role to axillary lymph node metastases

CAESAREA, Israel, Aug. 13, 2026 /PRNewswire/ -- IceCure Medical Ltd. (NASDAQ: ICCM) ("IceCure," "IceCure Medical" or the "Company"), developer of minimally invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal, today highlighted two recent peer-reviewed publications by leading U.S. experts that reinforce the growing clinical role of cryoablation in breast cancer treatment de-escalation. A new review cites ProSense®'s U.S. Food and Drug Administration ("FDA") marketing authorization, its inclusion in updated American Society of Breast Surgeons ("ASBrS") guidelines and encouraging outcomes from the five-year ICE3 clinical study (3.1% IBTR rate), while a second publication extends the clinical discussion of cryoablation to axillary lymph node metastases for both curative and palliative care.

IceCure Medical Logo

The first article, a review titled "Cryoablation within the Evolving Paradigm of Multidisciplinary Breast Cancer Treatment De-Escalation" (Yao, Ward & Dibble, Clinical Breast Cancer), examines the clinical evidence, procedural considerations, and place of breast cryoablation within the broader shift towards de-escalation of care – providing less burdensome and minimally intensive treatment approaches with similar safety and effectiveness outcomes to traditional surgical options. The review highlights ProSense®'s authorized use in selected early-stage, low-risk breast cancers in women aged 70 and older, and ongoing studies including IceCure's ChoICE post-marketing trial.

The second article, "Cryoablation of Axillary Lymph Node Metastases for the Curative and Palliative Treatment of Breast Cancer" (Huang et al., Journal of Breast Imaging), provides practical guidance on cryoablation of axillary lymph node metastases in patients who are poor surgical candidates or decline surgery. The authors note that cryoablation can be performed safely with high technical success and low complication rates, and for both curative and palliative care, expanding the clinical discussion of cryoablation beyond the primary tumor to regional nodal disease.

"These peer-reviewed publications by leading clinicians reflect the medical community's growing recognition of cryoablation as a meaningful option within breast cancer treatment de-escalation strategies," said Eyal Shamir, Chief Executive Officer of IceCure. "We believe the expanding body of peer-reviewed literature and clinical evidence will significantly support our commercialization efforts and the broader adoption of ProSense® worldwide."

About IceCure Medical

IceCure Medical (NASDAQ: ICCM) develops and markets advanced liquid-nitrogen-based cryoablation therapy systems for the destruction of tumors (benign and cancerous) by freezing, with the primary focus areas being breast, kidney, bone and lung cancer. Its minimally invasive technology is a safe and effective option to surgical tumor removal that is easily performed in a relatively short procedure. The Company's flagship ProSense® system is marketed and sold worldwide for the indications cleared and approved to date including in the U.S., Europe, and Asia.

Forward Looking Statements

This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be covered by the "safe harbor" created by those sections. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as "believe," "expect," "may," "should," "could," "seek," "intend," "plan," "goal," "estimate," "anticipate" or other comparable terms. For example, the Company is using forward-looking statements when it discusses the growing clinical role of cryoablation in breast cancer treatment de-escalation; the potential for peer-reviewed literature and clinical evidence, including the review's discussion of ProSense®'s FDA marketing authorization, updated ASBrS guidelines, five-year ICE3 clinical study outcomes and ongoing post-marketing studies, to support commercialization efforts and broader adoption of ProSense®; the potential use of cryoablation in selected early-stage, low-risk breast cancer patients; and the potential expansion of cryoablation's clinical role beyond in both curative and palliative care settings. Historical results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. Important factors that could cause actual results, developments and business decisions to differ materially from those anticipated in these forward-looking statements include, among others: the Company's planned level of revenues and capital expenditures; the Company's available cash and its ability to obtain additional funding; the Company's ability to market and sell its products; legal and regulatory developments in the United States and other countries; the Company's ability to maintain its relationships with suppliers, distributors and other partners; the Company's ability to maintain or protect the validity of its patents and other intellectual property; the Company's ability to expose and educate medical professionals about its products; political, economic and military instability in the Middle East, specifically in Israel; as well as those factors set forth in the Risk Factors section of the Company's Annual Report on Form 20-F for the year ended December 31, 2025 filed with the SEC on March 17, 2026, and other documents filed with or furnished to the SEC which are available on the SEC's website, www.sec.gov. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.

Investor Relations:
Meir Peleg, CFO
investors@icecure-medical.com
+1-888-902-5716

 

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SOURCE IceCure Medical

FAQ

What did IceCure Medical (NASDAQ: ICCM) announce on August 13, 2026?

IceCure Medical announced two new peer-reviewed U.S. publications supporting its ProSense® cryoablation technology in breast cancer treatment de-escalation. According to IceCure, the papers cover FDA marketing authorization, guideline inclusion, ICE3 five-year outcomes, and use in axillary lymph node metastases for curative and palliative care.

How do the new publications support ProSense® cryoablation for breast cancer treatment de-escalation (ICCM)?

The publications present clinical evidence and practical guidance positioning ProSense® cryoablation within less intensive breast cancer treatment strategies. According to IceCure, they highlight FDA marketing authorization, American Society of Breast Surgeons guideline inclusion, and favorable ICE3 five-year results, plus applications in axillary lymph node metastases.

What are the key results from the ICE3 five-year trial mentioned by IceCure Medical (ICCM)?

The ICE3 five-year study reported a 3.1% ipsilateral breast tumor recurrence (IBTR) rate in selected early-stage, low-risk breast cancers in women aged 70 and older. According to IceCure, these outcomes support ProSense® use within breast cancer treatment de-escalation approaches compared with traditional surgery.

How is cryoablation used for axillary lymph node metastases in breast cancer according to the new ICCM publication?

The second publication describes cryoablation of axillary lymph node metastases in breast cancer patients who are poor surgical candidates or decline surgery. According to IceCure, authors report safe procedures, high technical success and low complication rates, for both curative and palliative treatment settings.

Which patient population is highlighted for ProSense® breast cryoablation in the new IceCure publications?

The review emphasizes selected early-stage, low-risk breast cancers in women aged 70 and older for ProSense® use. According to IceCure, this aligns with de-escalation strategies that seek less burdensome, minimally invasive treatments offering similar safety and effectiveness to traditional surgical tumor removal.

How might these peer-reviewed articles impact IceCure Medical’s (ICCM) commercialization of ProSense®?

The articles add peer-reviewed clinical and practical evidence supporting ProSense® in breast and nodal cryoablation. According to IceCure, the expanding body of literature and ICE3 outcomes are expected to significantly support commercialization efforts and encourage broader worldwide adoption of ProSense® in appropriate breast cancer settings.